Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer

NCTNCT02749825Other idPUI-02809

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Withdrawal of funding support

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 41 participants (actual)
Sponsor: Pharmatech · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Sept 2002
Primary completion: May 2006
Completion: Jul 2006
First posted: 25 Apr 2016 (estimated)
Last update posted: 25 Apr 2016 (estimated)
Conditions: Prostate Cancer

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200220032004200520062007

Ph 4
Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer
NCT02749825
Sept 2002 to Jul 2006
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This research study looks at Testosterone levels in patients receiving Trelstar versus those receiving Lupron or Zoladex. These drugs have been approved for treatment of Prostate Cancer by the FDA.

Interventions

TrelstarDrug
LupronDrug
ZoladexDrug

Arms3

Experimental
Trelstar
Per prescribing information
Active comparator
Lupron
Per prescribing information
Active comparator
Zoladex
Per prescribing information

Primary outcomes1

Outcomes the sponsor listed as primary.

Maintenance of serum testosterone at or below castration level (50ng/dL)
Time frame · 12 weeks
Registry description
Primary efficacy

Secondary outcomes(3)

Serum testosterone level at end of study
Time frame · Week 12
Registry description
Secondary efficacy
Change in serum testosterone from baseline to end of study
Time frame · Baseline and week 12
Registry description
Secondary efficacy
Incidence and severity of adverse events
Time frame · 12 weeks
Registry description
Treatment tolerability

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Advanced Prostate Cancer * Currently taking Lupron or Zoladex * Stable PSA * Baseline testosterone below castration level * Life expectancy \> 6 months * Eastern Cooperative Oncology Group performance status of 0-2 * Signed, approved informed consent. Exclusion Criteria: * Known hypersensitivity to any leuteinizing hormone releasing hormone (LHRH) agonist * Ongoing therapy with hyperprolactinemic agents * Antiandrogen therapy within 28 days prior to study start * Prior Orchiectomy, hypophysectomy or adrenalectomy * Chemotherapy, radiotherapy, or prostatectomy within 28 days prior to study start * Use of any investigational agent 3 months prior to enrollment * Use of systemic corticosteroids within 28 days or during study * Other malignancies within 2 yrs prior to study start, except curatively treated skin cancers * Severe kidney or liver failure, based on adequate lab values * Other medical conditions which would be likely to interfere with compliance or completion of study requirements

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